FDA 510(k)

压平式眼压计 AT-2

K号: K182491 · 2018-12-10

决定日期2018-12-10

产品代码HKY

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决定实质等同

器械摘要

Applanation tonometer AT-2 is the device name listed in this FDA 510(k) record. The listed applicant is Takagi Seiko Co., Ltd.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K182491. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Applanation tonometer AT-2?

Applanation tonometer AT-2 is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Takagi Seiko Co., Ltd.. The 510(k) number is K182491.

When did Applanation tonometer AT-2 receive FDA 510(k) clearance?

Applanation tonometer AT-2 received FDA 510(k) clearance on 2018-12-10, under 510(k) number K182491.

Who is the listed applicant for Applanation tonometer AT-2?

The FDA 510(k) record lists Takagi Seiko Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Applanation tonometer AT-2?

The FDA product code for Applanation tonometer AT-2 is HKY.

列明Takagi Seiko Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K172728压平眼压计 AT-1 K162636Marco Ultra M3, Marco Ultra M4 K152535Z5 分光显微镜，Z2 分光显微镜

官方来源

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